Evaluation of CureXcell® in Treating Lower Extremity Chronic Ulcers in Adults With Diabetes

This study has been completed.

Sponsor:

Macrocure Ltd.

ClinicalTrials.gov Identifier:

NCT01421966

First Posted: August 23, 2011

Last Update Posted: December 7, 2015

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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Proportion of patients with complete healing/closure of their target ulcer at any time during the 16-week double-blind core treatment period with sustained complete closure for 4 additional weeks of follow-up. [ Time Frame: up to 20 weeks ]

Original Primary Outcome Measures ICMJE (submitted: August 22, 2011)

Proportion of patients with complete healing/closure of their target ulcer at any time during the 16-week double-blind core treatment period with sustained complete closure for 4 additional weeks of follow-up [ Time Frame: up to 20 weeks ]

Proportion of patients (and individual treated ulcers) with all ulcers completely healed/closed at any time during the 16-week double-blind core treatment period with sustained complete closure for 4 additional weeks of follow-up. [ Time Frame: up to 20 weeks ]

Time to complete closure/healing of all ulcers (and individual treated ulcers) during the 16-week core treatment period with sustained complete closure for 4 additional weeks of follow-up [ Time Frame: up to 20 weeks ]

Time to complete closure/healing of the target ulcer during the 16-week core treatment period with sustained complete closure for 4 additional weeks of follow-up. [ Time Frame: up to 20 weeks ]

Proportion of patients whose target ulcer (and individual treated ulcers) completely closed/healed during the 16-week core treatment period and remained closed at the Week 12 follow-up visit. [ Time Frame: up to 28 weeks ]

Proportion of patients whose target ulcer (and individual treated ulcers) had ulcer recurrence following complete closure during the 16-week core treatment period and during the 12-week follow-up period [ Time Frame: up to 28 weeks ]

Current Other Outcome Measures ICMJE

Not Provided

Original Other Outcome Measures ICMJE

Not Provided

Descriptive Information

Brief Title ICMJE

Evaluation of CureXcell® in Treating Lower Extremity Chronic Ulcers in Adults With Diabetes

Official Title ICMJE

A Phase III Multicenter, Randomized, Double-Blind, Parallel-Group, Sham-Controlled Study to Evaluate the Safety, Tolerability and Efficacy of CureXcell® as an Adjunct to Good Wound Care in Lower Extremity Chronic Ulcers in Adults With Diabetes Mellitus

Brief Summary

Chronic foot ulcers are particularly prevalent in patients with underlying diabetes mellitus. These ulcers are reported to be the leading cause of hospitalization among people with diabetes.

The purpose of this study is to evaluate CureXcell® in treating chronic lower extremity ulcers in adults with diabetes mellitus. CureXcell® is a cell based therapy, containing activated homologous white blood cells prepared from donated healthy whole blood. A total of 280 patients will be randomized to receive either CureXcell® or sham.

Detailed Description

Chronic foot ulcers are particularly prevalent in patients with underlying diabetes mellitus. The prevalence of diabetes mellitus is growing at epidemic rates in Europe, United States and in general worldwide. Foot ulceration is a serious complication of diabetes mellitus associated with increased risk of infection, gangrene and amputation. These ulcers are reported to be the leading cause of hospitalization among people with diabetes. Despite existing ulcer therapies and technologies, there continues to be a great necessity for new wound healing technologies that will further improve healing rates for these chronic ulcers that remain a major source of morbidity, concern, and cost. This Phase 3 multinational, multicenter, randomized, double-blind, controlled study is designed to evaluate CureXcell® in treating lower extremity chronic ulcers in adults with Diabetes Mellitus.

CureXcell® is a cell based therapy obtained from donated whole blood. The blood are collected from healthy, young adult (age 18-40), the cells separated and then activated by hypo-osmotic shock.

A total of 280 patients, in approximately 35 sites in the US, Canada and Israel, will be randomized to receive either CureXcell® or control.

The primary objective of the study is to evaluate the clinical benefit of CureXcell® (study biologic) compared to control, as adjunct to Good Ulcer Care. Additional objectives are to demonstrate safety, tolerability and durability of CureXcell® compared to control.

The study has two phases: a core double-blind phase and a follow up phase.

Males or females at least 18 years of age with diabetes type 1 or type 2;

Patients with HbA1c ≤ 12%;

Patients with at least one lower extremity (on or below the malleolus (ankle bone)), at least full-thickness ulcer (penetrating through the whole layer of the skin), which has been unresponsive to any treatment for at least 4 weeks;

Ulcers with an area between ≥ 1 cm2 and ≤ 20 cm2 (after sharp debridement of free, non-viable, hyperkeratotic and fibrotic tissue to the extent possible);

Ankle Brachial Index ≥ 0.65;

Exclusion Criteria:

Patients with more than two ulcers on the same foot or more than a total of three chronic ulcers;